AFIAS iFOB with AFIAS-50
K-Number: K163225 · 2017-08-08
ApplicantImmunostics Inc.,
Decision Date2017-08-08
Product CodeOOX
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
AFIAS iFOB with AFIAS-50 is a medical device manufactured by Immunostics Inc.,. It received FDA 510(k) clearance on 2017-08-08 under approval number K163225. The device is classified under product code OOX. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AFIAS iFOB with AFIAS-50?
AFIAS iFOB with AFIAS-50 is a medical device that received FDA 510(k) clearance on 2017-08-08. It is manufactured by Immunostics Inc.,. The 510(k) number is K163225.
When was AFIAS iFOB with AFIAS-50 approved by the FDA?
AFIAS iFOB with AFIAS-50 received FDA 510(k) clearance on 2017-08-08, under approval number K163225.
What company makes AFIAS iFOB with AFIAS-50?
AFIAS iFOB with AFIAS-50 is manufactured by Immunostics Inc.,.
What is the FDA product code for AFIAS iFOB with AFIAS-50?
The FDA product code for AFIAS iFOB with AFIAS-50 is OOX.
Other Devices by Immunostics Inc.,
Related Devices (Code: OOX)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.